D-0653-2026 Class II Ongoing
FDA drug recall D-0653-2026 was initiated by ACCORD BIOPHARMA INC on June 10, 2026 and is designated Class II. Reason for recall: Lack of assurance of Sterility: The recall status is ongoing. Affected quantity: 326 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2026
- Initiation Date
- June 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 326 vials
Product Description
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.
Reason for Recall
Lack of assurance of Sterility:
Distribution Pattern
US Nationwide.
Code Information
Lot # 004L24A, Exp Date: 02/19/2027.